GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Liver Cancer

GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Liver

This trial is to further study the safety and effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Cancer
• Intervention / Treatment: Biological: gp96

Detailed Description

RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.

Overall Goals:

- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.

Primary Aim:

- to further evaluate effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work.

Secondary Aims:

to study the immune response to vaccination, to monitor clinical responses , to further the safety of vaccine.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Able to read and understand the informed consent document; must sign the informed consent;
2. Aged 18 to 75 years old , sex is not limited;
3. must have undergone radical resection;AJCC TNM II、III、IV.
4. Availability of at least 1g tumor sample;
5. Adequate bone marrow function including the absence of lymphopenia (ANC > 1,500/ mm3; Hemoglobin > 10g/dL ; platelet count >100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], alanine amino transferase [ALT] <2.5 times institutional upper limit of normals [IULNs] ), and adequate renal function (BUN and creatinine <1.5 times IULNs)
6. Agree to Surgical indications of Heart & lung and without the coagulation system disease
7. Patients could not have received previous anti-cancer treat before 4 weeks of gp96 treatment；

Exclusion Criteria:

1. Inability to comply with study-related procedures
2. Unavailability of at least 6 doses of vaccine
3. Severe allergies
4. Unstable or severe intercurrent medical conditions
5. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection.
6. patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.
7. Female patients who are pregnant or breastfeeding
8. Steroidal drugs are currently being used systemically.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: gp96 group; Patients only receive autologous gp96 vaccination after surgery (do not accept other anti-tumor treatments) 6 times of gp96 vaccination are administered via subcutaneous injection in 25μg doses within 8 weeks after surgery. gp96 is administered once a week.	Biological: gp96; heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.
No Intervention: Control group; Patients do not accept any anti-tumor treatmentsafter surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
2-year recurrence-free survival rate	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		5 year
Disease free survival		5 year
changes in antigen specific T cells	tumor antigen specific T cells are determined by IFN-γ Enzyme-linked Tumor antigen specific T cells will be determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen	within 3 days before the first vaccination and within 10 days after the last vaccination
Number of participants with adverse events related to gp96 immunotherapy	A complete blood count will be requested before the first vaccination, after the second vaccination and after the last vaccination to monitor the side effect of gp96 immunotherapy. And blood chemistries will also be requested at the same time point for the same reason.And other adverse events related to gp96 immunotherapy will be recorded according to the NCI-CTCAE 5.0 criteria.	up to 3 months after vaccine completion

Collaborators and Investigators

• Sponsor: Cure&Sure Biotech Co., LTD
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): December 19, 2019
• Primary Completion (Anticipated): August 5, 2022
• Study Completion (Anticipated): August 5, 2023

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: CS-CH-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No